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Evaluate the Immunogenicity and Safety of the 2011-2012 Vaccine Against Seasonal Influenza on Pregnant Women

NCT01577316 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2012-04-13

No results posted yet for this study

Summary

The hypothesis proposed in this study is that the 2011-2012 Seasonal Influenza Vaccine (including H3N2 and H1N1 subtypes of serotype A strain over the serotype B) administered to 15ug (without adjuvant) via intramuscular in pregnant women will be safe and immunogenic.

Conditions

  • Pregnancy
  • Investigation or Care in A Nonpregnant Woman

Interventions

BIOLOGICAL

Seasonal influenza vaccination

2011-2012 Seasonal Trivalent Inactivated Influenza Vaccine (include A/California/7/2009 (H1N1)-like, A/Perth/16/2009 (H3N2)-like, and B/Brisbane/60/2008-like antigens) administered to 15ug without adjuvant, via intramuscular in pregnant and nonpregnant women. It is recommended that vaccines for use in the 2012-2013 influenza season (northern hemisphere winter) contain the following: * an A/California/7/2009 (H1N1)pdm09-like virus; * an A/Victoria/361/2011 (H3N2)-like virus; * a B/Wisconsin/1/2010-like virus.

Sponsors & Collaborators

  • Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.

    collaborator OTHER

  • Instituto Nacional de Salud Publica, Mexico

    lead OTHER

Principal Investigators

  • Lourdes Garcia Garcia, DCs · Instituto Nacional de Salud Publica, Mexico

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-12-31
Completion
2013-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01577316 on ClinicalTrials.gov